Faecal collector having breathable skin attachment means

ABSTRACT

A faecal management device has a bag and a flange. The faecal management device is placed on a wearer, in combination with an applicator. The applicator is configured to exert pressure from at least two spaced apart pressure points onto the flange of the device. The device is placed on a wearer by using placement lobes associated with the flange.

FIELD OF THE INVENTION

The present invention relates to a faecal management device for babies,children or adults to be attached to the perianal area of the wearer.More particularly it relates to an applicator for such a device, whichcan be used to place the device in the perianal area of a wearer.

BACKGROUND OF THE INVENTION

Faecal management devices are known articles of manufacture that aredesigned to be worn principally by incontinence sufferers and inparticular by bedridden patients. Such faecal management devices areattached to the perianal area of the wearer and are intended to entrapand immediately contain faecal material and other bodily discharges.

Such devices as they are mostly known today are constituted of arelatively long and narrow tube, at one extremity of which is positionedthe aperture and the attachment device, which can be adhesive. Such bagsare disclosed in, e.g. U.S. Pat. No. 3,577,989.

A problem naturally associated with these devices is their attachment tothe human body. The approach which is mostly used in the field is toprovide the device with an adhesive flange, which will stick to theperianal area.

U.S. Pat. Nos. 3,522,807 and 3,734,096 disclose faecal receptacleshaving an adhesive flange surrounding the aperture in the device, forattachment to the body of the patient in nursing or medicalapplications; said flange contains a plurality of tabs extendingoutwardly from the aperture and said tabs are covered with adhesive inthe same manner as the rest of the flange and thus are designed to serveas adhering aids, and must be covered by a release means before use ofthe receptacles.

In GB-A-2,116,849, it was attempted to provide an adhesive faecalincontinence device which, among other properties, was easier to put inplace on the patient. The solution brought up by GB-A-2,116,849 is,however, quite complex, involving individually removable sections of therelease layer covering the adhesive layer on the flange surrounding theaperture, said sections having to be removed in a predetermined sequencein order to ensure optimum adherence.

Besides and in connection with optimum adherence, the correct placementof the device is also a key issue in the field of faecal managementdevices. Total or substantial misplacement of the device will lead to asevere misfunctioning, in particular incomplete collection of faeces andleakage in leakage. If the aperture of the faecal management device isnot sufficiently in registry with the anal opening, substantialpressure, in particular on the flanges of the device, can build up inthe defecation process. Such substantial pressure can lead to thedetachment of the adhesively secured device, obviously entailing themost unwanted consequences.

If the misplacement of the device is recognised before use, theplacement of the device is normally corrected, typically by the carer.The necessary detachment and reattachment of the device causes anadditional stress on the affected areas of skin of the wearer. Manywearers, who make use of faecal management devices have a sensitive skindue to their age, whether very old or very young, and furthermoresometimes also suffer from skin irritations. Proper placement of thedevice in the first place is therefore highly desirable.

The faecal management devices which are disclosed in the mentioned priorart are normally handled and placed onto the skin of the wearer by usingthe flange itself. Typically, one of the first necessary handling stepsis the removal of the release paper from the adhesive surface of theflange. When then placing the device, the caretaker will normally touchthe adhesive area of the flange with the fingers and leave finger marks.Such marks will reduce the adhesive force of the affected areas of theadhesive surface, if dirt is deposited from the fingers or if anadhesive is used, which tends to adhere less on second contact with asurface.

Furthermore, during application of the faecal management device to thewearer by holding the flange, pressure typically needs to be exercisedupon the flange. However, as a result of such pressure the flange maysuffer deformation, leading to a poorer performance of the device, inparticular to a poorer adhesion, discomfort or possibly leaking of thedevice.

In Kokai Patent Application No. HEI8 (1996) 117 261, an externalaccessory is described to assist in the placement of the adhesive partof the disclosed diaper onto the wearer. Such a tool may help in theplacement of such an incontinence product when compared to the placementwithout any aide. However, the successful use of such a tool willrequire training, in particular if the tool is not specifically designedfor its purpose. A further problem with such a tool is that a caretaker,for example, when dealing with a bedridden patient, may have only onehand available for the application of the device.

Hence, there still exists a need for faecal management devices which canbe easily and correctly positioned onto the desired area of the wearerby the caretaker or wearer themselves without causing discomfort to thewearer or damage to the device.

In attempting to overcome all the aforementioned problems relating tothe prior art, it has now been found that a specifically designedapplicator which can be utilised with adhesive faecal management devicesgreatly facilitates the correct placement of the device. Furthermoresuch an applicator maintains the bag of the device in a foldedconfiguration prior to the use of the device and supports the hygienicand protective packaging of the device.

SUMMARY OF THE INVENTION

The present invention relates to a faecal management device (10)comprising a bag (11), said bag (11) having an aperture (21) and aflange (12) surrounding said aperture for adhesive attachment toperianal area of wearer. More particularly, the invention relates to anapplicator (40) for the placement of such a device (10) to the perianalarea of a wearer. Claimed and described is an applicator (40),comprising a handling portion (42); characterised in that saidapplicator (40) comprises at least two pressure points (42).

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed that the invention will be better understood from theforegoing description in conjunction with the accompanying drawings inwhich:

FIG. 1 is a perspective view of a preferred embodiment of a faecalmanagement device.

FIG. 2 is a perspective view of a diaper and a faecal management device,which can be worn in combination according to the present invention.

FIG. 3 is a partially cut-away perspective view of a diaper to be wornin combination with a faecal management device according to the presentinvention.

FIG. 4 is a schematic view of a first preferred embodiment of theapplicator.

FIG. 5 is a schematic view of a second preferred embodiment of theapplicator.

FIG. 6 is a schematic view of a third preferred embodiment of theapplicator, which is unfolded.

FIG. 7 is a schematic view of the preferred embodiment of the applicatoras described in FIG. 6, in combination with a preferred faecalmanagement device.

FIG. 8 is a schematic view of the preferred embodiment of the applicatoras described in FIG. 6, in combination with a preferred faecalmanagement device, in which the bag of said device is folded.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to a faecal management device (10) as shown inFIG. 1. The device (10) comprises a bag (11) and a flange (12).

Description of the Faecal Management Device as a Whole

Typically faecal management devices comprise a bag (11) having anaperture (21) and a flange (12) surrounding the aperture for preferablyadhesive attachment to the perianal area of a wearer as visible fromFIG. 1. Any faecal management device known in the art can be providedaccording to the present invention.

The bag (11) as used herein is a flexible receptacle for the containmentof excreted faecal matter. The bag (11) can be provided in any shape orsize depending on the intended use thereof, i.e. whether the device isintended for bedridden patients or active patients suffering fromincontinence or requiring an artificial bowel or for infants. Forexample, elongated bags which are principally tubular or rectangular aretypically utilised by bedridden patients and elderly incontinencesufferers. For more active wearers whether infants or adults, the faecalmanagement device should preferably be anatomically shaped such that thedevice follows the contours of the body and can be worn inconspicuouslyby the wearer under normal garments.

Particularly, preferred shapes are flat circular type bags, cone shapedbags, truncated cone shaped bags and pyramidal or truncated pyramidalbags. In a most preferred embodiment of the present invention, the bag(11) has a substantially truncated cone shape. Typically the bags willhave a wearer facing portion (16) and a garment facing portion (17). Thewearer facing portion (16) of the faecal management device (10) isdisposed adjacent the buttocks of the wearer. As such, the wearer facingportion (16) amply covers the buttocks of the wearer and does not hangbetween the thighs of the wearer.

In addition, the bag (11) is preferably shaped to allow at least partialinsertion and retention of the bag in-between the buttocks of the wearerand thereby ensure good contact between the flange and the skin of thewearer. For example, the bag (11) may be provided with a neck portion orconduit.

The bag (11) is preferably designed to provide sufficient volume forfaecal material under a variety of wearing conditions, also when worn bya freely moving, i.e. not bedridden wearer. Sitting on the bag, forexample, will result in a largely reduced volume in some areas of thebag. Thus, the bag is preferably shaped to provide sufficient volume inareas which are not subjected to much pressure in wearing conditionssuch as sitting.

The bag (11) is designed to safely contain any entrapped material,typically it will be liquid impermeable, yet it may be breathable. Thebag (11) is designed of sufficient strength to withstand rupture in use,also when pressure on the bag (11) is exerted in typical wearingconditions, such as sitting.

According to the present invention, depending on the shape of the bag(11) required, the bag (11) may be provided from a unitary piece ofmaterial or from a number of separate pieces of material, which may beidentical or different and which are sealed at their respectiveperipheries.

In one preferred embodiment the bags herein have a wearer facing portion(16) and a garment facing portion (17) which comprise separate pieces ofmaterial. The wearer facing portion (16) and the garment facing portion(17) are sealed at the periphery of the bag (11), thus creating a bagperipheral rim (18). As is visible from FIG. 1, the wearer facingportion (16) of the bag (11) may comprise two further sections (19),which are secured to each other by means known to the man skilled in theart, such as adhesive, thermobonding or pressure bonding in order toprovide the desired bag configuration. Said rim (18) may also be insidethe bag, thus being coextensive with the inner surface (15) of the bag(11) rather than with the outer surface (30) of the bag (11). Preferablythe bag (11) is asymmetrical to the transversal axis, so that thedistance measured in the longitudinal direction from the centre of theaperture (21) to the front end of the bag (11) is shorter than thedistance measured to the rear end of the bag (11).

According to the present invention the bag (11) can comprise one ormultiple layers, preferably two or three layers. The layer on the insideof the bag (11), which will typically at least partially come in contactwith faecal material is called the inner layer. The outermost layer ofthe bag, which will typically at least partially come in contact withthe skin to the wearer and the garments of the wearer, is called theouter layer.

The layers of the bag material may be provided from any material,preferably so that the bag is liquid impervious. The layers may inparticular comprise any material such as non-wovens or films. In apreferred embodiment of the present invention a laminate may be formedfrom a non-woven layer and a film. The laminate can be formed by meansknown to the man skilled in the art.

Any non-woven layer can comprise felt fabrics, spunlaced fabrics, fluidjet entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laidfabrics, melt-blown fabrics, staple fibre carding fabrics, spunbondedfabrics, stitch-bonded fabrics, apertured fabrics, combinations of theabove or the like.

Suitable film materials for any of said layers preferably comprise athermoplastic material. The thermoplastic material can be selected fromamong all types of hot-melt adhesives, polyolefins especiallypolyethylene, polypropylene, amorphous polyolefins, and the like;material containing meltable components comprising fibres or polymericbinders including natural fibres such as cellulose—wood pulp, cotton,jute, hemp; synthetic fibres such as fibreglass, rayon, polyester,polyolefin, acrylic, polyamid, aramid, polytetrafluroethylene metal,polyimide; binders such as bicomponent high melt/low melt polymer,copolymer polyester, polyvinyl chloride, polyvinyl acetate/chloridecopolymer, copolymer polyamide, materials comprising blends wherein someof the constituent materials are not meltable; air and vapour permeablematerials including microporous films such as those supplied by EXXONChemical Co., III, US under the designation EXXAIRE or those supplied byMitsui Toatsu Co., Japan under the designation ESPOIR NO; and monolithicbreathable materials such as Hytrel™ available from DuPont and Pebax™available from ELF Atochem, France.

In a preferred embodiment a film, which is comprised in any layer, ispreferably permeable to gases such as air and to vapour such as watervapour in order to avoid the problem of entrapment and condensation ofmoisture vapour given off by the body of the wearer and thus, the hot,clammy and uncomfortable conditions after a short period of use.

The outer layer of the bag is preferably provided with a non-wovenlayer. Such material layers present an uneven surface to the skin of thewearer and thus reduce significantly the problem of occlusion andgreatly improve skin healthiness.

In one preferred embodiment of the present invention the bag comprisestwo layers. Preferably the outer layer comprises a non-woven layer andthe inner layer comprises a film.

In yet another preferred embodiment of the present invention, the bag(11) comprises three layers, preferably one film and two non-wovenlayers. In an even more preferable embodiment the film is interposedbetween the two non-woven layers. This sequence of layers results in aclosed fibrous structure, which has a particularly pleasing sensation oncontact with the skin of the wearer. In yet another preferred embodimentthe inner layer comprises a film and the other two layers comprisenon-wovens.

The non-woven layer or the non-woven layers comprised by the bag (11)may be hydrophobic or hydrophilic. If the bag (11) does not comprise afilm layer, preferably at least one non-woven layer is hydrophobic. As aconsequence, fluid penetration is resisted through the wearer facingportion (16) and the garment facing portion (17) of the faecalmanagement device (10). If the bag comprises a film or a hydrophobicnon-woven layer, further non-woven layers may be hydrophilic.

Typically, the non-woven layer is treated with a surface activematerial, such as a fluorchemical or other hydrophobic finishings, toprovide the requisite hydrophobicity. The non-woven layer, however, mayequally be treated with coatings of liquid impervious materials such ashot-melt adhesives or coatings of silicone or other hydrophobiccompounds such as rubbers and vegetable and mineral waxes or it may bephysically treated using nano-particulates or plasma coating techniques,for example.

The non-woven layer can also be treated with agents to improve thetactile perceivable softness of the wearer facing portion (16) and thegarment facing portion (17). The agents include but are not limited tovegetable, animal or synthetic oils, silicone oils and the like. Thepresence of these agents are known to impart a silky or flannel-likefeel to the non-woven layer without rendering it greasy or oily to thetactile sense of the wearer. Additionally, surfactant material,including anionic, non-anionic, cationic and non-cationic surfactants,may be added to further enhance softness and surface smoothness.

Furthermore, the non-woven layer may be impregnated with a lotion toprovide desirable therapeutic or protective coating lotion benefits. Thelotion coating on the wearer facing portion (16) and the garment facingportion (17) is transferable to the skin of the wearer by normal contactand wearer motion and/or body heat. Generally, mineral oil in the formof a lotion is recognised as being effective in imparting a soothing,protective coating to the skin of the wearer. It is also possible toimpregnate the non-woven layer with a solid oil phase of creamformulation or to incorporate into the non-woven layer an array ofpressure- or thermal- or hydrorupturable capsules containing forexample, baby oil.

In one embodiment of the present invention the bag (11) may containabsorbent material. The absorbent material may comprise any absorbentmaterial which is capable of absorbing and retaining liquids. Theabsorbent material may comprise a wide variety of liquid-absorbentmaterials commonly used in disposable diapers and other absorbentarticles such as comminuted wood pulp, which is generally referred to asairfelt. Examples of other suitable absorbent materials include crepedcellulose wadding; meltblown polymers, including coform; chemicallystiffened, modified or cross-linked cellulosic fibers; tissue, includingtissue wraps and tissue laminates; absorbent foams; absorbent sponges;superabsorbent polymers; absorbent gelling materials; or any other knownabsorbent material or combinations of materials.

The absorbent material may be positioned in the bag (11) in any suitablemanner. For example, the absorbent material may be loosely arrangedwithin the bag or may be secured to the inner surface (15) of the bag(11). Any known techniques for securing absorbent material to nonwovenand film substrates may be used to secure the absorbent material to theinner surface (15) of the bag. The absorbent material may also bearranged to have any desired shape or configuration (e.g., rectangular,oval, circular, etc.).

As shown in FIG. 1 the bag (11) is provided with an aperture (21)whereby faecal matter is received from the body prior to storage withinthe bag cavity.

The aperture (21) is surrounded by a flange (12) and may be provided inany shape or size, such as circular, oblong, heart shaped and may besymmetrical or asymmetrical, preferably the aperture has an oblongconfiguration either in the longitudinal or in the transversal directionor in both directions, e.g. the contours of the aperture are in theshape of two ellipses with the respective main axes being substantiallyperpendicular.

The flange (12) is attached to the bag (11) according to any means knownto the man skilled in the art which may provide permanent or releasableattachment. Preferably however, the flange is attached to the bag byadhesive. Typically, the bag will be attached to the flange, towards theouter periphery of flange so as not to cause any obstruction for theentering faecal matter.

The flange may be provided in any size depending on the wearer group forwhich the device is intended. Similarly the flange may be provided inany shape and preferably has a symmetrical shape preferably comprising aplurality of lobes (13)/(14).

The flange comprises a garment facing portion (22) and a wearer facingportion (23). In an preferred embodiment these are two large,substantially flat surfaces, however, the flange (12) may also compriseprojections, a front projection (28) and/or a rear projection (29),designed to fit the perineal and/or coccygeal area of the wearer.

The flange (12) should be made of soft, flexible and malleable materialto allow easy placement of the flange (12) to the perianal area. Typicalmaterials include nonwoven materials, wovens, open celled thermoplasticfoams, closed-cell thermoplastic foams, composites of open celled foamsand stretch nonwoven, and films. A closed-cell foam of polyethylene hasbeen found effective, but more preferably an open celled polyurethanefoam is used. Preferably, such foams have a thickness within the generalrange of 0.1 to 5 millimeters and a density of 5 to 250 g/m², morepreferably 50 g/m². Other thermoplastic foam materials, or othersuitable plastics sheet materials having the described properties ofsuch foams (i.e., softness, pliability, stretchability, andcontractability) might also be used. Preferably, the material of garmentfacing portion (22) of the flange (12) may extend into the definedaperture area so as to form a skirt or flap of material which preventsunintentional adhesion of the surface edges of the flange (12) definingthe aperture (21) to one another during use.

According to the present invention the faecal management device (10)further comprises an attachment means to secure the device to thewearer. Such means include straps and more preferably comprises abody-compatible pressure sensitive adhesive (20) applied to the wearerfacing portion (23) of the flange (12).

The adhesive (20) is preferably covered with a release means (not shown)in order to protect the adhesive (20), such as siliconized paper. Theadhesive (20) can cover the entire wearer facing portion (23) of theflange (12) or more preferably have at least one, preferably two to sixnon-adhesive portions. These portions may be adhesive free or maycontain inactivated or covered adhesives. As is evident from FIG. 1, theadhesive is in one preferred embodiment not applied to the entire wearerfacing portion (23) of the flange (12), so as to provide lobes (13)/(14)on either side of the flange (12) which are non-adhesive and can therebyserve to facilitate placement and removal of the device whilst avoidingcontact with the adhesive. These lobes (13)/(14) are however preferablyalso covered by the release means. Before application of the faecalmanagement device (10) to the skin of the wearer, the release means ifpresent is removed.

According to the present invention any medically approved waterresistant pressure sensitive adhesive may be used to attach the deviceto the perianal area of the wearer, such as hydrocolloid adhesives andhydrogel adhesives. Particularly effective adhesives in providing thedesired adhesive properties to secure the flange to the skin of thewearer at the sensitive perianal area, whilst allowing for relativelypainless application and removal, are formed from crosslinking polymerswith a plastisicer to form a 3-dimensional matrix.

The adhesive (20) can be applied to the wearer facing portion (23) ofthe flange (12) by any means known in the art such as slot coating,spiral, or bead application or printing. Typically the adhesive (20) isapplied at a basis weight of from 20 g/m² to 2500 g/m², more preferablyfrom 500 g/m² to 2000 g/m² most preferably from 700 g/m² to 1500 g/m²depending on the end use envisioned. For example, for faecal managementdevices (10) to be used for babies the amount of adhesive (20) may beless than for faecal management devices (10) designed for active adultincontinence sufferers.

Detailed Description of a Diaper to be Worn in Combination with theFaecal Management Device

The faecal management device (10) of the present invention has beenfound to be particularly useful and beneficial when used in conjunctionwith a garment, or diaper (50), preferably a disposable diaper—refer toFIG. 2. The faecal management device (10) is preferably first placed inthe perianal area of the wearer before the disposable diaper (50) isapplied. In particular, the diaper (50) is positioned over the faecalmanagement device (10) and fastened in a conventional manner around thebody of the wearer. It has been found that, in addition, to providingexcellent separation between urine and faecal material, the combinedfaecal management device (10) and diaper (50) system actually reducesskin irritation, which may at times occur, especially since the group oftypical wearers includes the very old, the very young and the unhealthywearers.

In effect, the presence of the faecal management device (10) permits theformation of a separation layer between the skin of the wearer and thediaper (50), i.e. a part of the absorbent core (58) of the diaper (10).The diaper (50) can be of the conventional type (an embodiment of whichis described below although not a limiting example by any means) or canbe adapted to contain in an effective and comfortable manner the faecalmanagement device (10) according to the teachings of the presentinvention.

As used herein, the term “disposable diapers” refers to articles whichabsorb and contain body extrudates; and more specifically, refers toarticles which are placed against or in proximity to the body of thewearer to absorb and contain the various extrudates discharged from thebody and which are intended to be discarded after a single use (i.e.,they are not intended to be laundered or otherwise restored or reused)and, preferably, to be recycled, composted or otherwise disposed of inan environmentally compatible manner. As used herein, the term “diaper”refers to a garment generally worn by infants or incontinence sufferersthat is drawn up between the legs and fastened about the waist of thewearer.

FIG. 3 is a partially cut-away perspective view of a diaper (50)embodying the present invention prior to it being placed on the wearerover the faecal management device (10). As is visible from FIG. 3, apreferred diaper (50) comprises a body portion (52) and a refastenablemechanical fastening device (54). A preferred body portion (52)comprises a liquid pervious topsheet (56), and absorbent core (58), aliquid impervious backsheet (60), and elastically contractible leg cuffs(62); each leg cuff (62) preferably comprising a side flap (64) and oneor more elastic members (66). For simplicity purposes, only one elasticmember (66) is shown in the side flap (64). While the topsheet (56), theabsorbent core (58), the backsheet (60), the side flaps (64), and theelastic members (66) may be assembled in a variety of well-knownconfigurations. A preferred disposable diaper configuration is shown andgenerally described in U.S. Pat. No. 3,860,003, an even more preferreddisposable diaper configuration is shown and generally described in WO93/16669. In this preferred diaper configuration, the backsheet (60) isjoined to the topsheet (56); the absorbent core (58) is positionedbetween the topsheet (56) and the backsheet (60); the side flaps (64)extend outwardly from and along each side edge of the absorbent core(58); and the elastic member (66) is operatively associated with eachside flap (64).

FIG. 3 shows the body portion (52) in which the topsheet (56) and thebacksheet (60) are coextensive and have length and width dimensionsgenerally larger than those of the absorbent core (58). The topsheet(56) is superposed on the backsheet (60) thereby forming the periphery(68) of the body portion (52).

The body portion (52) has an inside surface (74) and an outside surface(76). When a backsheet (60) is used, it typically forms the outsidesurface (76) of the body portion (52). The inside surface (74) is thatsurface of the diaper (50) opposite the outside surface (76) and in theembodiment shown is typically formed by the topsheet (56). In general,the inside surface (74) of the diaper (50) is that surface coextensivewith the outside surface (76) and which is for the greater part incontact with the wearer when the diaper (50) is worn.

The absorbent core (58) of the body portion (52) may be any absorbentmeans which is generally compressible, conformable, non-irritating tothe skin of the wearer, and capable of absorbing and retaining liquidssuch as urine and other certain bodily discharges. The absorbent core(58) may be manufactured in a variety of sizes and shapes (for example,rectangular, hour-glass, “T”-shaped, asymmetric, etc.) and from a widevariety of liquid absorbent materials commonly used in disposablediapers and other absorbent articles such as comminuted wood pulp whichis generally referred to as airfelt. Examples of other suitableabsorbent materials include creped cellulose wadding, meltblown polymersincluding coform, crosslinked cellulosic fibers, tissue including tissuewraps, absorbent foams, absorbent sponges, superabsorbent polymers,absorbent gelling materials, or any equivalent materials or combinationsof materials. The configuration and construction of the absorbent core(58) may also be varied (for example, the absorbent core (58) may havevarying caliper zones, hydrophilic gradients, superabsorbent gradients,or lower average density and lower average basis weight acquisitionzones; or may comprise one or more layers or structures). Further, thesize and absorbent capacity of the absorbent core (58) may be varied toaccommodate wearers ranging from infants to adults.

The backsheet (60) is impervious to liquids (for example, urine) and ispreferably manufactured from a thin plastic film, preferably athermoplastic film, although other flexible liquid impervious materialsmay also be used. As used herein, the term “flexible” refers tomaterials which are compliant and which will readily conform to thegeneral shape and contours of the human body. The backsheet (60)prevents the exudates absorbed and contained in the absorbent core (58)from soiling articles which are in contact with the diaper (50) such asundergarments and bedding. The backsheet (60) may thus comprisepolymeric films such as thermoplastic films of polyethylene orpolypropylene, or composite materials such as film-coated non-wovenmaterial. Exemplary films are manufactured by Tredegar Industries, Inc.of Terre Haute, Ind., USA or BP-Chemical Plas Tec, Rotbuchenstrasse 1,D-8000 München, Germany.

The backsheet (60) is preferably textured to provide a more clothlikeappearance. Further, the backsheet (60) may also permit vapours toescape from the absorbent core (58) while still preventing exudates frompassing through the backsheet (60) by, for example, being supplied withmicroapertures. The size of the backsheet (60) is dictated by the sizeof the absorbent core (58) and the exact diaper design selected.

The topsheet (56) of the diaper is compliant, soft feeling andnon-irritating to the skin of the wearer. Further, the topsheet (56) isliquid pervious permitting liquids (for example, urine) to readilypenetrate through its thickness. A suitable topsheet (56) may bemanufactured from a wide range of materials, such as porous foams,reticulated foams, apertured films; or woven or non-woven webs ofnatural fibres (for example, wood or cotton fibres) or from acombination of natural and synthetic fibres. Preferably, it is made of amaterial that isolates the skin of the wearer from liquids retained inthe absorbent core (58).

There are a number of manufacturing techniques which may be used tomanufacture the topsheet (56). For example, the topsheet (56) may be anon-woven web of fibres. An exemplary topsheet (56) is carded andthermally bonded by means well-known to those skilled in the fabric art.A suitable topsheet (56) is manufactured by, for example, Veratec Inc.,a division of International Paper Company, of Walpole, Mass., USA. Atopsheet (56) particularly preferred for incontinence garments comprisesa formed thermoplastic film.

Detailed Description of the Applicator

To allow a more detailed and clear description of the present invention,in the following paragraphs firstly a number of terms, as used herein,will be defined.

Regarding the faecal management device (10) the longitudinal axis is tobe understood as follows: The direction which is substantially definedby the anal groove in the intended wearing position shall define thelongitudinal direction. The longitudinal axis is an axis in thelongitudinal direction, which crosses the centre of the aperture (21).The most preferred indication of the intended wearing position is thepresence of one or two projections (28) and/or (29) designed to fit theperineal or coccygeal area of the wearer, a less preferred indication ofthe intended wearing position is a fold in said flange (12) prior to useintended to be placed in parallel to the anal groove when placing theproduct. The longitudinal axis is typically also an axis of symmetry ofthe bag (11).

The transversal axis is an axis perpendicular to said longitudinal axis,which crosses the centre of the aperture (21). The bag (11) is typicallynot symmetrical to the transversal axis.

Longitudinal, when used for the applicator (40), shall denote thedirection which is substantially parallel to the longitudinal directionof the faecal management device (10) when the applicator (40) is usedfor placing the device (10). Typically the pressure points (42) arealigned along a longitudinal axis.

The garment facing portion (17) is the portion of the bag (11), which isgenerally oriented away from the wearer, when the faecal managementdevice (10) is worn, and towards a garment, if a garment is worn. Thegarment facing portion (17) does not comprise the aperture (21). Thesize and the shape of the garment facing portion (17), in particular itslength and width, are defined by the bag peripheral rim (18). Sectionsof material comprised by the rim (18) or seal do not form part of thegarment facing portion (17).

The wearer facing portion (16) is the portion of the bag (11), whichcomprises the aperture (21) and is generally oriented towards thewearer, when the faecal management device (10) is worn. The size and theshape of the wearer facing portion (16) are defined by the bagperipheral rim (18). Sections of material comprised by the rim (18) orseal do not form part of the wearer facing portion (16).

Centre is used to describe a point of an object or a part of an object,which coincides with the centre of mass, if said object or part were ofuniform density.

Thus for the aperture (21), the centre is to be determined when the areawithin the contour of the aperture (21) is considered to be filled witha material of uniform thickness and density, when the flange (12) isunbent.

Unbent is used with regard to the flange (12). The flange (12) istypically bent along a longitudinal axis to place it onto the perianalarea of the wearer. In an unbent state the flange (12) is typicallyflattest. Flat is used in the description of a three-dimensional object,such as the flange (12), if the object can be thought to be fullycontained by a cuboid, characterised by three characterising lengths, ofwhich one first length is less than half of either of the two othercharacterising lengths. If the object is flexible in shape, so that itmay take several shapes without a substantial effect on its propertiesor damage, it is called flat if it is flat in one of said shapes. Suchan flexible object is in its flattest shape if said first characterisinglength is minimal.

The invention relates to an applicator (40) to be used for the placingof a faecal management device (10) to the perianal area of a wearer,preferred applicators (40) are shown in FIGS. 4 to 6.

Preferably the faecal management device (10), which is to be used incombination with the applicator (40), is provided with pressuresensitive adhesive (20) on the flange (12) for adhesive attachment tothe skin in the perianal area of a wearer. For secure attachment of thedevice (10) pressure thus needs to be exerted onto the device and theskin of the wearer to ensure adhesion. While this can be done, forexample through the bare hands and fingers, it has now been found thatthe use of an applicator allows the caretaker or wearer to exert morepressure and is of great help in ensuring that pressure is exerted in acontrolled manner onto the correct areas.

In addition the utilisation of the applicator (40) also greatly assistsin assuring that the bag (11), which is preferably provided in a foldedconfiguration prior to the placing of the device (10), remains in thatfolded configuration during application. The applicator (40) was alsofound to provide hygienic and mechanical protection for the device (10).Furthermore the applicator (40) was found to assist in the economic,aesthetically pleasing and protective packaging of the faecal managementdevice (10).

The applicator (40) according to the present invention is thusconfigured so as to exert pressure from at least two pressure points(42) preferably onto the flange (12) of the faecal management device(10). Such a configuration has been found beneficial for the secureattachment of a faecal management device (10) without causing pain tothe wearer and without being particularly difficult or time consumingfor the person placing the device (10).

In a preferred embodiment the applicator (40) exerts pressure onto twopoints, as easily seen in FIG. 4. Preferably these two pressure points(42) have a position and a distance chosen so as to exert pressure ontothe perineal and the coccygeal area of a wearer, but more preferably notonto the sphincter muscle and the anus of a wearer. Their position thuslargely depends on the intended wearer group and on the faecalmanagement device (10) used in combination with the applicator (40).Preferred faecal management devices (10) are provided with one or twoprojections, a front projection (28) and/or a rear projection (29),designed to fit the perineal and/or coccygeal area of the wearer. Theseprojections help in ensuring a good seal between the flange (12) and thebody of the wearer and thus ensure the complete collection of faecalmatter in the defecation process and prevent leaking of faecal materialcollected by the device (10). If such projections (28) and/or (29) arepresent, the applicator (40) for the device (10) is preferably providedwith pressure points (42) which exert pressure onto these projections(28) and/or (29) by contacting the corresponding areas on the garmentfacing portion (17) of the flange (12).

Other preferred embodiments may have more than two pressure points (42).For example, it may be beneficial to exert pressure on said projections(28) and/or (29) and on other selected points, e.g. two additionalpoints on the anal groove of the wearer (by having contact with thecorresponding areas on the garment facing portion (17) of the flange(12)) to further improve the seal and fit of the flange (12) on thewearer.

In yet another preferred embodiment one of the pressure points (42),e.g. a central protrusion as depicted in FIG. 6, is positioned so as toexert pressure into the anus and is hereinafter referred to as a centralpressure point (42). Preferably, such a central pressure point (42) isbrought in registry with the aperture (21) of the faecal managementdevice (10) before and/or whilst placing the device (10). This centralpressure point (42) does not typically assist in pressing the adhesive(20) onto the skin of a wearer, but helps the wearer/caretaker to bringthe aperture (21) in registry with the anus. It has been found that thepresence of such a central pressure point (42) is particularly helpfulin ensuring the correct placement of the device, since it allows theperson placing the device to follow and feel the contours of thewearer's body by keeping said central pressure point (42) in contactwith the wearer's body. Bringing said central pressure point (42) inregistry with the anus of the wearer can then ensure the placing of theaperture (21) in registry with the wearer's anus, which is highlyimportant for the correct functioning of a faecal management device(10).

If no such central pressure point (42) as described above is present,the other pressure points (42) are preferably positioned so that the twopressure points (42), which are closest to the anus of the wearer, whenthe device (10) is placed, are separated from one another by at least 1cm, preferably by at least 3 cm, more preferably by at least 5 cm. Ifonly two pressure points (42) are present on an applicator (40) intendedfor faecal management devices (10) for babies their distance ispreferably 1 to 15 cm, more preferably 3 to 12 cm, more preferably 5 to10 cm apart from one another. If one central pressure point (42) ispresent, it is preferably positioned centrally between the two pressurepoints (42), which are closest to the anus of the wearer, when thedevice (10) is placed. This central pressure point (42) does not need tobe symmetrical to the neighbouring two pressure points (42), since in apreferred embodiment the device (10) itself is not symmetrical to thetransversal axis: The distance measured in the longitudinal directionfrom the centre of the aperture (21) to the front end of the bag (11) ispreferably shorter than the distance measured in the longitudinaldirection from the centre of the aperture (21) to the rear end of thebag (11).

According to the present invention said pressure points (42) of theapplicator (40) are to be understood as areas, which typically have anon-negligible size (as opposed to points in a narrow mathematicalsense). The area is preferably not so small that damage is done to thefaecal management device (10) or that pain is caused to the wearer. Thearea of the pressure points (42) is on the other hand preferably not toolarge regarding the anatomy of an intended wearer, so that theapplicator (40) exerts pressure only in the perianal area of the wearerand preferably can be used in-between the buttocks of a wearer.Preferably the surface area of each of said pressure points (42) isindependently from 0.01 mm² to 500 mm², more preferably from 0.1 mm² to50 mm², however the area largely depends on the particular embodiment ofthe applicator (40) and the faecal management device (10) to be used incombination with the applicator (40).

The applicator (40) is typically used by a person, whether the wearer ora caretaker, and typically handled by that person using the hands. Thus,to be held and to be used to exert pressure by the caretaker or wearer,the applicator typically comprises a handling portion (44). Thishandling portion (44) may comprise separate pieces of material, as shownin FIG. 4, or may be an integral part of the applicator (40), as shownin FIGS. 5 and 6. Also, separate portions of the unfolded applicator(40) may form part of the handling portion (44) of the folded applicator(40), without these separate portions comprising separate pieces ofmaterial, as shown in FIG. 5.

The applicator (40) may further comprise various labels, e.g. colourlabels. One such label can be used to indicate which portion of theapplicator is to be brought in registry with a particular portion of thefaecal management device (10). For example, a colour label may indicatewhich portion of the applicator (40) is to be brought in registry withthe centre of the aperture (21). Such a colour label should preferablystill be visible also when covered by the bag (11), in particular whencovered only by one layer of the material of the bag (11). Thus, saidcolour label is typically visible through the aperture (21) when theapplicator (40) is combined with the faecal management device (10) andindicates how to place the device (10) in registry with the anus of awearer by using the applicator (40).

Similarly colour labels on the applicator (40) can be also used toindicate how the applicator in combination with the faecal managementdevice (10) is to be oriented for placement, e.g. with regard to theperineal and the coccygeal areas of a wearer. Furthermore the applicator(40) can be labelled to provide usage instructions or any other writteninstructions.

An applicator (40) according to a present invention can be made in avariety of shapes and from a variety of materials. The applicator (40)may be made from one unitary piece of material or may comprise severalpieces of material.

The applicator (40) for the faecal management device (10) can be made ofany suitable material. The material should allow the transfer of therequired forces from the handling portion (44) of the applicator (40) tothe pressure points (42). Preferably the material is inexpensive andsuitable for a mass manufacturing process. Preferably the material isenvironmentally friendly for disposal, in particular for flushing in atoilet.

Preferred materials are wood, metal, plastic and cardboard. Cardboardmaybe be provided with a coating, e.g. a wax coating to improve thehygienic handling of the applicator (40) and to prevent any dirt fromeasily sticking to or otherwise soiling the applicator (40). Preferablythe cardboard has a thickness from 0.01 to 5 mm, more preferably from0.1 to 1 mm, most preferably from 0.3 to 0.7 mm.

Preferred materials also include those used for tampon applicators,which are typically provided from plastics, polymers or flushable smoothsurfaced cardboard. Materials such as paper or wood pulp which are alsoused for tampon applicators are hence also within the scope of thepresent invention. More preferred materials are disclosed in EP 613672A1, where a commercially effective and aesthetically-acceptablerapidly-disintegrating water-soluble disposable tampon applicator and amethod for making it are disclosed. The materials disclosed in EP 613672A1 such as water-soluble polymers having a coating comprising awater-insoluble polymeric material selected from the group consisting ofwax (comprising natural wax and synthetic wax), hydrogenated vegetableoil, and food grade shellac, may also be utilised for the applicationherein. Among the preferred water-soluble polymers is polyvinyl alcoholand thermoplastic starch.

According to the present invention, the applicator (40) may be providedin numerous configurations having pressure points (42), which providethe benefits as described herein. A first preferred embodiment of theapplicator (40), which is depicted in FIG. 4, comprises a handlingportion (44) and two pegs. Preferably this embodiment is made fromplastic material. The applicator is symmetrical to its longitudinalaxis. The handling portion (44) is open towards the pegs, thus forming acavity. The ends of the pegs pointing away from the handling portion(44) comprise the pressure points (42). The pegs comprise a base pieceand are flexibly joined to the handling portion (44) by adhesive incontact with this base piece. This first embodiment of the applicator(40) when dimensioned to be used for a faecal management device (10) fora baby has the following lengths and widths: The pegs have a length of 4cm and a width of 8 mm. The distance between the pegs measured at thehandling portion (44) along a straight line is 9 cm. The pegs areflexible so that the distance between the pressure points (42) can beincreased and so that the pegs can exert a force directed towards eachother. When combined with a faecal management device (10) this force canbe used to hold the applicator (40) and the device (10) together. Thecavity of the handling portion (44) then assists in maintaining the bag(11) in a folded configuration, since parts of the bag (11) extend intothat cavity.

A second preferred embodiment of the applicator (40) is depicted in FIG.5 and is preferably made from cardboard. It comprises three pressurepoints (42). The applicator (40) also comprises two notches to hold arubber band in place. When this embodiment of the applicator (40) isdimensioned to be used for a faecal management device (10) for a baby,the longitudinal length measured between the two notches is 12.5 cm, thelongest width measured perpendicular to said length is 10.3 mm and thecardboard used has a thickness of 0.5 mm.

The third preferred embodiment of the applicator (40), which is depictedin FIG. 6, is also preferably made from cardboard. It comprises twopressure points (42). The applicator (40) comprises a central orificeand is folded to provide the handling portion (44) which enclose partsof the bag (11). The applicator is symmetrical to its longitudinal axis.When this embodiment of the applicator (40) is dimensioned to be usedfor a faecal management device (10) for a baby, the length measuredalong the longitudinal axis is 8.5 cm, the longest width measuredperpendicular to said length is 13 mm. The cardboard used has athickness of 0.5 mm. While this embodiment is not symmetrical to thetransversal axis, a cardboard embodiment comprising an orifice, which issymmetrical to a transversal and to a longitudinal axis, is also apreferred embodiment.

In a preferred embodiment the faecal management device (10) is providedin a particular configuration prior to use. In that configuration, theflange (12) is folded along the longitudinal axis to allow easierplacement of the flange (12) in-between the buttocks of a wearer.Furthermore the bag (11) is preferably folded, which provides numerousadvantages. For example, folding of the bag (11) allows a smallerpackaging format of the device (10), thus reducing the costs fortransport and packaging material. Furthermore, the handling of thedevice (10) is more convenient if the bag (11) is folded, since e.g. thebag (11) may otherwise cover the placement lobes (13) or the handlingportion (44) of the applicator (40). The bag (11), when not folded, mayalso cover parts of the body of the wearer, so that the person placingthe device (10) cannot sufficiently visually control the placing.

Numerous patterns for the folding of the bag (11) are within the scopeof the present invention. The folding should result in a sufficientlysmall size of the bag (11) in its folded state to provide the benefitsdescribed above, should not cause damage to the bag and should allow anuncomplicated unfolding of the bag after placement.

For example, the bag (11) may be folded in the following way: As a firststep the bag (11) is folded (17) along two transversal lines, so thatdiametrically opposed portions of the rim (18) lie over the garmentfacing portion and preferably do overlap over a length of about 5 mm; asa second step the partially folded bag (11) is folded (17) along twolongitudinal lines, so that diametrically opposed portions of the rim(18) lie over the garment facing portion and preferably do overlap overa length of about 5 mm; as a third step the partially folded bag (11) isfolded (17) along the longitudinal axis so that diametrically opposedportions of the wearer facing portion (16) touch each other.Alternatively the folding steps described above as first step and secondstep can be carried out in inverted sequence, so that the bag (11) isfirst folded along two longitudinal lines.

Most preferably the applicator (40) and the faecal management device(10) in combination are provided in a particular configuration prior touse. This allows ready application of the faecal management device (10)with only a few handling steps, since there is no need to have separateitems at hand (the applicator (40) and the device (10)) and to positionthe applicator on the appropriate areas of the faecal management device(10) for application.

The applicator (40) may be provided with a means to hold the applicator(40) and the faecal management device (10) together. This means willtypically also ensure the correct positioning of the applicator (40)relative to the device (10) and help to maintain the foldedconfiguration of the bag (11), if the bag is folded. Such a meanspreferably are provided in the form of any string or band, which may beprovided in form of a closed loop, such as a rubber band. Such a meansmay also be provided in form of a clamp or a clip, made from anysuitable material such as plastic or metal.

FIGS. 7 and 8 describe one preferred combination of an applicator (40)and a faecal management device (10) comprising an applicator (40) asdepicted in FIG. 6, which comprises two pressure points (42) and acentral orifice. Most preferably the bag (11) is folded as describedabove and illustrated in FIG. 8. The applicator (40) is positioned so,that the central orifice of the applicator (40) and preferably thehandling portion (44) enclose portions of the bag (11), preferablyportions of the wearer facing portion (16) which are close to the flange(12). If the bag (11) is provided with a neck portion or conduit, theorifice of the applicator (40) will be positioned to enclose theseportions. For the positioning of the two pressure points (42) thoseareas of the wearer facing portion (16) which are relevant will be incontact with the perineal and the coccygeal area of the wearer, in apreferred embodiment projections (28) and (29) are present in theseareas. The pressure points (42) of the applicator (40) are brought inregistry with the areas of the garment facing portion (17) which areopposite to said areas of the wearer facing portion (16) as can be seenin FIG. 7. The handling portions (44) of the applicator (40) are thenadjacent to the placement lobes (13), which are present in a preferredembodiment of the faecal management device (10), as illustrated in FIG.8. The flange (12) and the applicator (40) are bent along thelongitudinal axis, the angle of bending being 135° to 180°, preferably160° to 180°. The folding of the applicator (40) maintains the foldingof the bag (11). A rubber band can be used to ensure the bending of theapplicator (40) and the flange (12). The folded applicator (40) providesmechanical and hygienic protection for the faecal management device(10).

Another and even more preferred combination of the applicator (40) and afaecal management device (10) comprises the applicator (40) depicted inFIG. 5. Most preferably the bag (11) is folded as described above. Theapplicator (40) is positioned in-between the fold of the bag (11) alongthe longitudinal axis. Thus, the bag (11) covers the portions to eitherside of the applicator (40) adjacent to the handling portions (44). Thecentral pressure point (42) is positioned to lie in registry with thecentre of the aperture (21) of the device (10). The other two pressurepoints (42) of the applicator (40) are brought in registry with saidareas of the garment facing portion (17) and enable the exertion ofpressure onto the coccygeal and perineal areas of the wearer. Thenotches in the applicator (40) depicted in FIG. 5 can be used to hold inplace a rubber band. This rubber band covers parts of the flange (12)and of the bag (11). Hence, the rubber band maintains the positioning ofthe bag (11) relative to the applicator (40) and helps to maintain thefolded configuration of the bag (11).

Placing a faecal management device (10) which is provided in combinationwith an applicator (40) by using the applicator (40) by a personcomprises the following handling steps:

a) unpacking of the faecal management device (10) and the applicator(40);

b) holding the device (10), which preferably comprises placement lobes(13), and the applicator (40) by using the placement lobes (13) on theflange (12) and/or using the handling portion (44) of the applicator(40);

c) removing the release means from the adhesive (20) provided on saidflange (12), preferably using one hand for the removal of the releasemeans while holding the device (10) and the applicator (40) with theother hand;

d) supporting the placement body position of the wearer, using one hand,e.g. holding up the babies legs, while holding the device (10) and theapplicator (40) with the other hand;

e) placing said device (10) in the perianal area of the wearer by usingthe placement lobes (13) on the flange (12) and/or using the handlingportion (44) of the applicator (40);

f) letting said adhesive (20) on said flange (12) attach to the body ofthe wearer;

g) exerting pressure towards the perineal area of the wearer, thecoccygeal area of the wearer or other areas of the wearer to be incontact with the adhesive (20), or a combination thereof, by using theapplicator (40), either at the same time or in any sequence;

h) releasing the grasp of the placement lobes (13);

i) separating of the applicator (40) from the device (10) while holdingit using the handling portion (44), e.g. by pulling in a directionsubstantially away from the perianal area of the wearer;

j) unfolding the bag (11) so that it covers the buttocks of the wearer.

Depending on the used embodiment of the present invention and conditionsof the placement numerous other handling steps in placing the device(10) using an applicator (40) may also be undertaken, different handlingsteps may be undertaken or certain of the mentions handling steps maynot be involved.

What is claimed is:
 1. A method for a caretaker or a wearer for theplacement of a faecal management device, comprising two placement lobes,using an applicator to be used for the placement of a faecal managementdevice on a wearer, the applicator comprising a handling portion, saidmethod comprises the steps of: holding said faecal management device bythe placement lobes on the flange and/or the handling portion of theapplicator with a first hand; removing the release means from theadhesive provided on said flange, using a second hand for the removal ofthe release means while holding said faecal management device and saidapplicator with said first hand; supporting the body position of thewearer for placement using the second hand, while holding said faecalmanagement device and said applicator with said first hand; placing saiddevice in the perianal area of the wearer by using the placement lobeson the flange and/or using said handling portion; letting said adhesiveon said flange attach to the body of the wearer; exerting pressuretowards the perineal area of the wearer, the coccygeal area of thewearer or other areas of the wearer to be in contact with said adhesive,or a combination thereof, by using said applicator, either at the sametime or in any sequence; releasing the grasp of said placement lobes;separating of said applicator from said faecal management device whileholding said applicator using said handling portion; unfolding said bagso that said bag covers the buttocks of the wearer.